What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections - Recorded Webinar

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Angela Bazigos

OVERVIEW:
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

Why should you Attend: It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same. ICH Q7 was established by US / EU and Japan to harmonize inspections in their respective countries